Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

  • NDC Code(s): 36800-564-01, 36800-564-02
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 4, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purpose
    Bacitracin zinc USP 400 unitsFirst aid antibiotic
    Neomycin sulfate USP 3.5 mgFirst aid antibiotic
    Polymyxin B sulfate USP 5,000 unitsFirst aid antibiotic
  • Uses

    first aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only.

    Do not use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition persists or gets worse
    • rash or other allergic reaction develops

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the affected area
    • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • Other information

    • To open: unscrew cap, pull tab to remove foil seal
    • store at 20° to 25°C (68° to 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

  • Questions?

    Call 1-888-423-0139

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    TopCare®
    health™

    ORIGINAL STRENGTH

    • OUR PHARMACISTS
    RECOMMEND •

    Triple Antibiotic Ointment
    BACITRACIN ZINC, NEOMYCIN SULFATE & POLYMYXIN B SULFATE
    First Aid Antibiotic Ointment

    NET WT 1 OZ (28.4 g)

    NDC 36800-564-02

    Principal Display Panel - 28.4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-564
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin400 [iU]  in 1 g
    Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    cocoa butter (UNII: 512OYT1CRR)  
    cottonseed oil (UNII: H3E878020N)  
    olive oil (UNII: 6UYK2W1W1E)  
    sodium pyruvate (UNII: POD38AIF08)  
    .alpha.-tocopherol (UNII: H4N855PNZ1)  
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-564-011 in 1 CARTON11/30/2016
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:36800-564-021 in 1 CARTON11/30/2016
    228.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B12/15/2015
    Labeler - Topco Associates LLC (006935977)
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